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临床试验/NCT07676760
NCT07676760尚未招募不适用

The Role of High-Flow Nasal Cannula in Monitoring Postoperative Atelectasis With Lung Ultrasonography After Laparoscopic Surgery: A Prospective Observational Study

Bursa Yuksek Ihtisas Training and Research Hospital0 个研究点目标入组 90 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
主要终点
Total Lung Ultrasonography Score (LUS Score)

研究概览

简要总结

Pneumoperitoneum and Trendelenburg positioning during laparoscopic surgery promote atelectasis development, which has been reported in up to 90% of patients under general anesthesia and increases the risk of postoperative pulmonary complications. High-flow nasal cannula (HFNC) oxygen therapy may reduce post-extubation atelectasis through alveolar recruitment. This prospective observational cohort study aims to evaluate the role of HFNC in postoperative atelectasis monitored by lung ultrasonography (LUS) in patients undergoing elective laparoscopic surgery.

详细描述

General anesthesia with laparoscopic surgery causes cephalad diaphragm displacement and reduction in functional residual capacity due to pneumoperitoneum and Trendelenburg positioning, predisposing patients to atelectasis development. Perioperative atelectasis has been reported in up to 90% of patients under general anesthesia, increasing the risk of hypoxemia, prolonged oxygen therapy, and postoperative pulmonary complications (PPCs).

High-flow nasal cannula (HFNC) oxygen therapy supports alveolar recruitment, enhances mucociliary clearance, and may reduce post-extubation atelectasis through heated and humidified gas delivery and generation of low-level positive end-expiratory pressure (PEEP). Randomized controlled trials have demonstrated that HFNC significantly reduces the incidence and severity of atelectasis assessed by LUS in robot-assisted laparoscopic rectal cancer surgery. Lung ultrasonography (LUS) has emerged as a reliable, rapid, and radiation-free method for diagnosis and monitoring of perioperative atelectasis with 87.7% sensitivity and 92.1% specificity.

This study is designed as a prospective, observational, single-center, parallel-group cohort study. No intervention or randomization will be performed. HFNC application will be left entirely to the clinician's discretion; the investigator will not be involved in the treatment process.

Patients in whom HFNC is initiated by the clinician in the post-extubation period will be defined as Group 1 (HFNC group), and patients receiving conventional oxygen therapy will be defined as Group 2 (Control group). HFNC application will be considered valid if initiated within 30 minutes of extubation.

LUS assessments will be performed by an independent investigator blinded to group assignment at four time points: T0 (preoperative), T1 (post-extubation), T2 (30th minute in the recovery unit), and T3 (discharge from the recovery unit). An additional LUS assessment is planned at postoperative 24 hours (T4). The Monastesse modified LUS score will be used at each assessment, evaluating 12 thoracic regions (6 segments per hemithorax along parasternal, anterior axillary, and posterior axillary lines), with a total LUS score ranging from 0 to 36 points.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18 years and older
  • Patients scheduled for elective laparoscopic surgery (general surgery, urology, gynecology)
  • Patients undergoing mechanical ventilation under general anesthesia
  • ASA physical status I-III
  • Patients providing written informed consent

排除标准

  • Severe or uncontrolled chronic obstructive pulmonary disease, asthma, or other chronic pulmonary diseases
  • Patients with atelectasis or pleural effusion detected on preoperative lung ultrasonography
  • Patients requiring intraoperative recruitment maneuver
  • ASA physical status IV or above
  • Patients receiving spinal or epidural anesthesia
  • Cases requiring conversion to laparoscopy or laparotomy
  • Patients refusing to participate

结局指标

主要结局

Total Lung Ultrasonography Score (LUS Score)

时间窗: T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit

Total lung ultrasonography score assessed using the Monastesse modified LUS scoring system. Each hemithorax is divided into 6 segments along parasternal, anterior axillary, and posterior axillary lines, evaluating a total of 12 thoracic regions with a total score ranging from 0 to 36 points. Scores are compared between HFNC and conventional oxygen therapy groups.

次要结局

  • Incidence of Significant Atelectasis(T0: preoperative; T1: 5th minute after extubation; T2: 30th minute in the recovery unit; T3: discharge from the recovery unit)
  • Minimum SpO₂ in the Post-Anesthesia Care Unit (PACU)(From extubation to PACU discharge, up to 2 hours)
  • Incidence of Hypoxemia(From extubation to PACU discharge, up to 2 hours)
  • Incidence of Severe Hypoxemia(From extubation to PACU discharge, up to 2 hours)
  • Postoperative Complications(From surgery to hospital discharge, up to 7 days)

研究者

发起方
Bursa Yuksek Ihtisas Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Selvinaz Yüksel Tanrıverdi

Anesthesiologist

Bursa Yuksek Ihtisas Training and Research Hospital

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